Package leaflet: Information for the patient - …

1 1 Package leaflet: Information for the patient Pradaxa 110 mg hard capsules dabigatran etexilate Read all of this leaflet carefully before you start taking this medicine because it contains important Information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Pradaxa is and what it is used for 2. What you need to know before you take Pradaxa 3. How to take Pradaxa 4. Possible side effects 5.

2 How to store Pradaxa 6. Contents of the pack and other Information 1. What Pradaxa is and what it is used for Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body which is involved in blood clot formation. Pradaxa is used in adults to: - prevent the formation of blood clots in the veins after knee or hip replacement surgery. - prevent blood clots in the brain (stroke) and other blood vessels in the body if you have a form of irregular heart rhythm called nonvalvular atrial fibrillation and at least one additional risk factor. - treat blood clots in the veins of your legs and lungs and to prevent blood clots from re-occurring in the vein of your legs and lungs. 2. What you need to know before you take Pradaxa Do not take Pradaxa - if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).

3 - if you have severely reduced kidney function. - if you are currently bleeding. - if you have a disease in an organ of the body that increases the risk of serious bleeding ( stomach ulcer, injury or bleeding in the brain, recent surgery of the brain or eyes). - if you have an increased tendency to bleed. This may be inborn, of unknown cause or due to other medicines. - if you are taking medicines to prevent blood clotting ( warfarin, rivaroxaban, apixaban or heparin), except when changing anticoagulant treatment, while having a venous or arterial line and you get heparin through this line to keep it open or while your heart beat is being restored to normal by a procedure called catheter ablation for atrial fibrillation. 2 - if you have a severely reduced liver function or liver disease which could possibly cause death.

4 - if you are taking oral ketoconazole or itraconazole, medicines to treat fungal infections. - if you are taking oral cyclosporine, a medicine to prevent organ rejection after transplantation. - if you are taking dronedarone, a medicine used to treat abnormal heart beat. - if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C. - if you have received an artificial heart valve which requires permanent blood thinning. Warnings and precautions Talk to your doctor before taking Pradaxa. You may also need to talk to your doctor during treatment with Pradaxa if you experience symptoms or if you have to undergo surgery. Tell your doctor if you have or have had any medical conditions or illnesses, in particular any of those included in the following list: - if you have an increased bleeding risk, such as: if you have been recently bleeding.

5 If you have had a surgical tissue removal (biopsy) in the past month. if you have had a serious injury ( a bone fracture, head injury or any injury requiring surgical treatment). if you are suffering from an inflammation of the gullet or stomach. if you have problems with reflux of gastric juice into the gullet. if you are receiving medicines which could increase the risk of bleeding. See Other medicines and Pradaxa below. if you are taking anti-inflammatory medicines such as diclofenac, ibuprofen, piroxicam. if you are suffering from an infection of the heart (bacterial endocarditis). if you know you have impaired kidney function, or you are suffering from dehydration (symptoms include feeling thirsty and passing reduced amounts of dark-coloured (concentrated) urine). if you are older than 75 years.

6 If you weigh 50 kg or less. - if you have had a heart attack or if you have been diagnosed with conditions that increase the risk to develop a heart attack. - if you have a liver disease that is associated with changes in the blood tests. The use of Pradaxa is not recommended in this case. Take special care with Pradaxa - if you need to have an operation: In this case Pradaxa will need to be stopped temporarily due to an increased bleeding risk during and shortly after an operation. It is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor. - if an operation involves a catheter or injection into your spinal column ( for epidural or spinal anaesthesia or pain reduction): it is very important to take Pradaxa before and after the operation exactly at the times you have been told by your doctor.

7 Tell your doctor immediately if you get numbness or weakness of your legs or problems with your bowel or bladder after the end of anaesthesia, because urgent care is necessary. - if you fall or injure yourself during treatment, especially if you hit your head. Please seek urgent medical attention. You may need to be checked by a doctor, as you may be at increased risk of bleeding. 3 - if you know that you have a disease called antiphospholipid syndrome (a disorder of the immune system that causes an increased risk of blood clots), tell your doctor who will decide if the treatment may need to be changed. Children and adolescents Pradaxa is not recommended in children and adolescents below 18 years old. Other medicines and Pradaxa Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

8 In particular you should tell your doctor before taking Pradaxa, if you are taking one of the medicines listed below: - Medicines to reduce blood clotting ( warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid) - Medicines to treat fungal infections ( ketoconazole, itraconazole), unless they are only applied to the skin - Medicines to treat abnormal heart beats ( amiodarone, dronedarone, quinidine, verapamil). If you are taking amiodarone, quinidine or verapamil containing medicines, your doctor may tell you to use a reduced dose of Pradaxa depending on the condition for which Pradaxa is prescribed to you. See section 3. - Medicines to prevent organ rejection after transplantation ( tacrolimus, cyclosporine) - A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C) - Anti-inflammatory and pain reliever medicines ( acetylsalicylic acid, ibuprofen, diclofenac) - St.

9 John s wort, a herbal medicine for depression - Antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin-norepinephrine re-uptake inhibitors - Rifampicin or clarithromycin (two antibiotics) - Anti-viral medicines for AIDS ( ritonavir) - Certain medicines for treatment of epilepsy ( carbamazepine, phenytoin) Pregnancy and breast-feeding The effects of Pradaxa on pregnancy and the unborn child are not known. You should not take Pradaxa if you are pregnant unless your doctor advises you that it is safe to do so. If you are a woman of child-bearing age, you should avoid becoming pregnant while you are taking Pradaxa. You should not breast-feed while you are taking Pradaxa. Driving and using machines Pradaxa has no known effects on the ability to drive or use machines. 3. How to take Pradaxa Always take this medicine exactly as your doctor has told you.

10 Check with your doctor if you are not sure. Take Pradaxa as recommended for the following conditions: Prevention of blood clot formation after knee or hip replacement surgery The recommended dose is 220 mg once a day (taken as 2 capsules of 110 mg). 4 If your kidney function is decreased by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg). If you are taking amiodarone, quinidine or verapamil containing medicines the recommended dose is 150 mg once a day (taken as 2 capsules of 75 mg). If you are taking verapamil containing medicines and your kidney function is decreased by more than half, you should be treated with a reduced dose of 75 mg Pradaxa because your bleeding risk may be increased. For both surgery types, treatment should not be started if there is bleeding from the site of operation.